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Celcuity (CELC) investor relations material

Celcuity Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary14 Aug, 2025

Executive summary

  • Achieved statistically significant and clinically meaningful improvements in both primary endpoints for the PIK3CA wild-type cohort in the Phase 3 VIKTORIA-1/VICTORIA-one trial for HR+/HER2- advanced breast cancer, with gedatolisib reducing risk of progression or death by 76% and significant PFS improvements.

  • Enrollment ongoing for PIK3CA mutant cohort and additional pivotal trials; topline data for mutant cohort expected in Q4 2025.

  • First patient dosed in Phase 3 VIKTORIA-2/VICTORIA-two trial for first-line HR+/HER2- ABC; favorable early results in prostate and breast cancer studies.

  • Issued new patent for gedatolisib dosing regimen, extending exclusivity to 2042.

  • Raised over $286M through equity, convertible notes, and warrant offerings to fund operations and clinical development.

Financial highlights

  • Q2 2025 net loss was $45.3M ($1.04/share), up from $23.7M ($0.62/share) in Q2 2024; non-GAAP adjusted net loss was $40.5M ($0.93/share) vs. $22.2M ($0.58/share) year-over-year.

  • R&D expenses rose to $40.2M from $22.5M, mainly due to increased personnel, trial costs, and a $5M milestone payment to Pfizer.

  • General and administrative expenses increased to $3.8M, reflecting higher personnel and professional fees.

  • Ended Q2 with $168.4M in cash and equivalents; pro forma including Q3 financing, cash position is $455M.

  • Interest expense for the quarter was $3.2M, up 42% year-over-year due to increased debt.

Outlook and guidance

  • NDA submission for gedatolisib planned for Q4 2025; topline data for PIK3CA mutant cohort also expected in Q4 2025.

  • Cash, investments, and available borrowings expected to fund operations and commercialization through 2027.

  • Anticipated increases in R&D and G&A expenses as clinical programs expand and commercialization preparations accelerate.

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Frequently asked questions

Celcuity Inc. is a biotechnology company focused on developing diagnostic tests to improve the treatment of cancer. The company specializes in functional cellular analysis, using its proprietary CELsignia platform to identify molecular and cellular changes in a patient’s cancer cells. This technology helps detect new cancer subtypes and matches patients with targeted therapies that are most likely to be effective. The company is headquartered in Minneapolis, Minnesota, and its shares are listed on the NASDAQ.

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